600% Kurspotential YM Biosciences 911799
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MISSISSAUGA, ON, Sept. 23 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI,
TSX:YM), today reported operational and financial results for its fiscal year
end, ended June 30, 20
"This has been a transformative year for YM. Our most notable development
was the merger of the public Australian company, Cytopia, into YM BioSciences,
completed in January, from which we gained two important clinical stage drug
candidates, CYT387 and CYT997, as well as a library of more than 4,000 novel
compounds in addition to the ongoing advancement of nimotuzumab by us and our
four licensees," said David Allan, Chairman and CEO of YM BioSciences. "Work
on CYT387, a potent, orally-administered JAK1/JAK2 inhibitor, has resulted in
favorable biological activity and safety data observed in recent months and as
such have announced the expansion of our current Phase I/II program in
myelofibrosis initiated at Mayo Clinic from 60 to up to 120 patients and the
inclusion of up to six centers in the United States, Canada and Australia. We
also look forward to the American Society of Hematology (ASH) meeting in
Orlando, Florida, in early December 2010, where detailed safety and
preliminary activity data for CYT387 are expected to be presented."
"During the fiscal period we raised an additional $20 million in two
financings that brought in a number of highly regarded life-sciences investors
as shareholders and we also recently announced the appointment of Dr. Nick
Glover as President and COO of YM. By strengthening both our balance sheet and
leadership team we have positioned YM to seize the significant new
opportunities that our expanded pipeline presents," added Mr. Allan.
<<
Highlights from Fiscal 2010:
CYT387
- Pivotal preclinical efficacy data for CYT387 in myeloproliferative
neoplasms were published in Blood, the Journal of the American
Society of Hematology (Blood, 24 June 2010, Vol. 115, No. 25, pp.
5232-5240).
- Subsequent to quarter end, Mayo Clinic concluded dose-escalation in
the Phase I portion of the Phase I/II clinical trial of CYT387 in
patients with myelofibrosis, a chronic debilitating condition where
the patient's bone marrow is replaced by scar tissue. In total, 21
patients were treated in Phase I, with no voluntary withdrawals
reported. CYT387 showed significant activity in reducing spleen size
and controlling constitutional symptoms in these patients. To date,
27 patients have been enrolled into the Phase II tranche bringing the
total number in the study to 48. Given the favorable biological
activity and safety data, the Company intends to expand enrolment for
the trial and include centers in the US, Canada and Australia,
subject to regulatory approval.
- Subsequent to quarter end, CYT387 was granted Orphan Drug Designation
by the US FDA. Orphan Drug Designation is granted to novel drugs or
biologics that treat a rare disease or condition affecting fewer than
200,000 patients in the US.
Nimotuzumab
- Wholly-owned subsidiary, YM BioSciences USA Inc. (YM-USA) received a
license from the US Department of the Treasury's Office of Foreign
Assets Control (OFAC) to further develop its humanized monoclonal
antibody, nimotuzumab, for patients with solid tumor cancers in the
US. YM-USA subsequently received FDA clearance to enroll patients
from US clinical sites into two ongoing randomized, double-blind
Phase II trials of its product, nimotuzumab. Subsequent to quarter
end, YM enrolled the first US patient in its randomized, double-blind
trial evaluating nimotuzumab in patients with brain metastases from
non-small-cell lung cancer (NSCLC) at the Florida Cancer Institute -
New Hope.
- YM reported that its licensee for nimotuzumab, Daiichi Sankyo Co.,
Ltd. in Japan advised that it has completed enrollment of a Phase II
trial evaluating nimotuzumab in combination with radiation
therapy/cisplatin/vinorelbine in first-line curative intent patients
with Stage III NSCLC. YM further anticipates that Daiichi Sankyo will
be in possession of data from its Phase II gastric cancer trial
evaluating nimotuzumab in combination with irinotecan in calendar
2010.
- YM reported in an oral presentation at the American Society for
Therapeutic Radiology and Oncology (ASTRO) 2009 Annual Meeting
positive 48-month survival data for its product, nimotuzumab. The
"BEST" trial was a randomized four-arm study treating patients with
inoperable, locoregionally-advanced, Stage III/IVa head and neck
cancer with radiation alone, chemoradiation alone, or radiation or
chemoradiation in combination with nimotuzumab.
- YM was advised that nimotuzumab had been approved for marketing in
Mexico, the 20th country to have approved the drug.
- YM anticipates reporting data from its North American Phase II
pediatric glioma trial in calendar 2010; that its licensee for
Europe, Oncoscience AG, will be in possession of European Phase III
adult glioma data for nimotuzumab in calendar 2010; and that it will
continue to support the scale-up and process enhancement for
manufacturing of nimotuzumab which are required for increased late-
stage clinical activity and in anticipation of requirements for
commercial volumes of product.
CYT997
- A poster presentation at the 2009 AACR-NCI-EORTC Molecular Targets
and Cancer Therapeutics conference in Boston, Massachusetts,
demonstrated CYT997's potent vascular disrupting effects and enhanced
antitumor effects in combination with cisplatin in preclinical
models. In August 2010, Phase I clinical trial results of CYT997 were
published in the premier cancer journal, the British Journal of
Cancer, demonstrating that CYT997 was well tolerated at doses that
were associated with changes in plasma and imaging biomarkers
consistent with vascular disruption in tumors.
Corporate Highlights
- Created YM Australia from the merger into YM of an Australian
biotechnology company, Cytopia Ltd., a company focused on the
discovery and development of new drugs to treat cancer and other
diseases.
- Raised US$17.5 million in March 2010, followed by a subsequent
investment of US$3.2 million made in June by a leading international
health-care-specific investment fund management company specifically
in support of the CYT387 program.
- Appointed Dr. Nick Glover to the newly created position of President
and Chief Operating Officer. Dr. Glover will provide broad leadership
to the Company and have primary responsibility for its operations and
infrastructure, in particular the development and commercialization
of YM's pipeline. The Company also announces that Mr. Robert Watson
has resigned as a director of YM BioSciences effective September
2010, that Mr. Sean Thompson, Vice President, Corporate Development,
has left YM BioSciences, effective August 2010, and that Ms. Wendy
Chapman and Dr. Ernest Wong have been appointed as Vice President,
Clinical Operations and Vice President, Business Development
respectively.
- Terminated all further expenditures related to the AeroLEF(R)
program.
>>
Financial Results (CDN dollars)
Total revenue (out-licensing revenue and interest income) for the fiscal
year ended June 30, 2010 was $2.7 million compared to $5.6 million for fiscal
2009. Total revenue for the fourth quarter of fiscal 2010 was $0.5 million
compared to $0.8 million for the fourth quarter of fiscal 2009. Revenue from
out-licensing was $2.6 million for fiscal 2010 compared to $4.5 million for
fiscal 2009. The decrease is mainly attributable to the full recognition of
all contracts related to the development of tesmilifene because all of YM's
obligations under the licensing agreement have been met.
Licensing and product development expenses were $17.0 million for the
fiscal year ended June 30, 2010 compared with $14.2 million for fiscal 2009.
Licensing and product development expenses were $7.6 million for the fourth
quarter of fiscal 2010 compared to $2.6 million for the fourth quarter of
fiscal 2009. The increases were almost entirely the consequence of non-cash
write-off of the AeroLEF intangible assets and the amortization of the Cytopia
intangible asset.
Costs associated with development activities for nimotuzumab were $5.6
million for the fiscal year ended June 30, 2010 compared to $6.0 million for
the previous year. Costs associated with development activities for
nimotuzumab were $1.8 million for the fourth quarter of fiscal 2010, compared
with $1.3 million for the same quarter of the previous year. The minor
differences mainly relate to two clinical trials, one for brain metastases
from non-small cell lung cancer (NSCLC) and the other for NSCLC patients
ineligible for radical chemotherapy. Recruitment into both trials lags
expectations and the targeted recruitment period is under review as a
consequence. Total development expenses decreased as result of the conclusion
of the Phase II pediatric pontine glioma and colorectal trials.
Costs associated with development activities for AeroLEF were $0.6
million for the fiscal year ended June 30, 2010 compared to $1.7 million for
the previous year. Costs associated with development activities for AeroLEF
were $0.1 million for the fourth quarter of fiscal 2010, compared to $0.2
million the previous year. In June 2010, the Company decided to no longer
pursue the AeroLEF program, and to terminate the development program
associated with the product. Accordingly, the net asset remaining on the
balance sheet was written off in Q4 of fiscal 2010.
General and administrative expenses were $6.9 million for the fiscal year
ended June 30, 2010 compared to $4.8 million for the previous year with the
majority of the increase accounted for by acquisition costs and non-cash
expenses. General and administrative expenses for the fourth quarter of fiscal
2010 were $1.8 million compared to $1.3 million for the same quarter in the
prior year. This increase is largely attributable to increased travel and
salaries with the acquisition of YM Australia.
Net losses for the fiscal year and fourth quarter ended June 30, 2010
were $21.0 million ($0.33 per share) and $8.6 million ($0.11 per share)
respectively, compared to $13.1 million ($0.23 per share) and $3.3 million
($0.06 per share) for the same periods last year.
As at June 30, 2010 the Company had cash and short-term deposits
totalling $45.6 million and accounts payables and accrued liabilities
totalling $2.8 million compared to $42.1 million and $0.9 million respectively
at June 30, 2009. Management believes that the cash and short-term deposits at
June 30, 2010 are sufficient to support the Company's activities for at least
the next twelve months.
As at June 30, 2010 the Company had 80,359,623 common shares and
8,166,480 warrants outstanding.
The Company's annual financial statements and management's discussion and
analysis will be available on www.sedar.com, www.edgar.com and at
www.ymbiosciences.com
Wird die nächsten Tage wieder schön abwärts bis 1.20 $ fallen.
Hier braucht man einfach Geduld, sobald es mal irgend wann eine Zulassung gibt (könnte sich aber noch Jahre hinziehen), gehts ab hier. Aber bis dahin könnten auch noch KE hinzu kommen...
phantasie kann auch kurse treiben
YM BioSciences reported that Pulmokine Inc., a licensee of several small molecule compounds from YM, has been awarded two National Institutes of Health, or NIH, Small Business Innovation Research, or SBIR, grants. The grants, totaling more than $650,000, are Phase I awards to develop novel treatments for Pulmonary Arterial Hypertension, or PAH. These compounds, originating from YM BioSciences' small molecule library, have defined mechanisms of action and, based on preliminary experiments, are believed to inhibit key processes in PAH disease development and progression. YM will continue to have a role in the ongoing development of the compounds. :theflyonthewall.com
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MISSISSAUGA, ON, Oct. 1 /PRNewswire-FirstCall/ -- YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), today announced it will present preclinical results for its CYT387 JAK1/JAK2 inhibitor program demonstrating that CYT387 possesses an excellent enzymatic potency and selectivity profile which may provide significant clinical advantages. CYT387 is currently being investigated in a Phase I/II clinical study at Mayo Clinic in patients with myelofibrosis. The results will be presented in a poster session at the European School of Haematology International (ESH) International Conference on Myeloproliferative Neoplasms in Albufeira, Portugal held from September 30-October 2, 2010.
"The ESH International Conference showcases leading research in the area of hematology and our participation among other highly-regarded hematological programs highlights the significance of our CYT387 program, which compares very favorably with other JAK inhibitors" said Dr. Nick Glover, President and COO of YM BioSciences. "The encouraging progress our JAK1/JAK2 inhibitor, CYT387, has been showing in the clinic is further reinforced by these data demonstrating that our product may have competitive advantages over other JAK inhibitors currently in development. We look forward to the American Society of Hematology (ASH) meeting in Orlando, Florida, in early December 2010, where detailed preliminary clinical data for CYT387 are expected to be presented."
The ESH poster will be presented at 5:30pm on Saturday, 2nd October. An online version of the poster will be available on the YM BioSciences website at http://www.ymbiosciences.com/.
About YM BioSciences
YM BioSciences Inc. is a drug development company advancing three clinical-stage products: CYT387, a small molecule, dual inhibitor of JAK1/JAK2 kinase; nimotuzumab, an EGFR-targeting monoclonal antibody; and CYT997, a potent vascular disrupting agent (VDA).
CYT387 is an orally administered inhibitor of both the JAK1 and JAK2 kinase enzymes, which have been implicated in a number of immune cell disorders including myeloproliferative disorders and inflammatory diseases as well as certain cancers. CYT387 is currently in a Phase I/II trial in myelofibrosis with detailed initial safety and activity data expected at the American Society of Hematology (ASH) meeting in December 2010. Nimotuzumab is a humanized monoclonal antibody targeting EGFR with a potential best-in-class side effect profile. Nimotuzumab is being evaluated in numerous Phase II and III trials worldwide by YM's licensees. CYT997 is a uniquely orally-available agent with dual mechanisms of vascular disruption and cytotoxicity, and is currently in a Phase II trial for glioblastoma multiforme. In addition to YM's three clinical stage products, the Company has a library of more than 4,000 novel compounds identified through internal research conducted at YM BioSciences Australia which are currently being evaluated.
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that our JAK1/2 inhibitor CYT387 and our VDA small molecule CYT997 will generate positive efficacy and safety data in future clinical trials; that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
YM BioSciences Inc.
CONTACT: Enquiries: James Smith, the Equicom Group Inc., Tel.
+1-416-815-0700 x 229, Email: jsmith@equicomgroup.com; Thomas Fechtner, the
Trout Group LLC, Tel. +1-646-378-2931, Email: tfechtner@troutgroup.com
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Mit innovativen Produktkandidaten punktet die kanadische Biotech-Schmiede YM Biosciences (YMI). Nach Jahren der Forschung soll 2010 das Jahr der Wahrheit für die Kanadier werden. Die Ergebnisse klinischer Studien sollen beweisen, dass der Krebsantikörper Nimotuzumab nicht nur deutlich weniger Nebenwirkungen hat, sondern mindestens ebenso wirksam ist wie etwa das Konkurrenzmittel Erbitux.
Ein lohnenswertes Übernahmeziel wäre YM Biosciences allemal. Schließlich sind die
Kanadier kein klassisches „One-Trick-Pony“. Neben Nimotuzumab, das sich gegen viele wichtige Krebsindikationen in fortgeschrittenen Entwicklungsphasen befindet, hat das Unternehmen der Pipeline durch die Übernahme der australischen Cytopia Anfang des Jahres zwei weitere Kandidaten hinzugefügt.
Mit in die Ehe brächte YM Biosciences einen Barbestand von rund 40 Millio-
nen Dollar. Die Kombination aus Hoffnungsträgern mit Blockbuster-Potenzi-
al, also der Aussicht auf Spitzenumsätze jenseits der Milliarden-Dollar-Marke, und einem hohen Barbestand, machen aus YM Biosciences ein potenzielles Opfer, an dem die meisten Pharmakonzerne Interesse haben dürften.
Kursziel: 2,00€
Quelle: Der Aktionär, aktuelle Ausgabe 41/2010
Hoffe sie bleibt selbstständig und verdient dann selbst ordentlich an ihren Produkten!
hatte mir aber geschworen, wenn der Kurs bei 1,63 € steht verkaufe ich...
Meine Gier wird aber nicht vor 7,50€ vekaufen wollen ;-)